Cleared Traditional

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

K251352 · Codonics.Incorporated · Anesthesiology
Jul 2025
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K251352 is an FDA 510(k) clearance for the Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration), a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Codonics.Incorporated (Middleburg Heights, US). The FDA issued a Cleared decision on July 11, 2025, 72 days after receiving the submission on April 30, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K251352 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2025
Decision Date July 11, 2025
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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